Events

Retiro De Equipo (Recall) de Health o Meter Professional

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Pelstar, Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60031
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0294-2012
  • Fecha de inicio del evento
    2011-10-07
  • Fecha de publicación del evento
    2011-11-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104272
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Scale, stand-on, patient - Product Code FRI
  • Causa
    There is a potential for an electrical short when installing or replacing the batteries in the remote display head of the scales. this short may cause the batteries to smoke, burn or burst.
  • Acción
    Pelstar LLC. sent a Urgent Device Recall letter dated October 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed them of the potential of an electrical short caused when installing or replacing the batteries which may result in minor injuries to the person installing the batteries. The customers were requested to immediately examine their inventory and quarantine all product subject to the recall. In addition, if they distributed this product to end users, they were requested to identify all customers and notify them of this product recall at once in writing, using the enclosed recall notification letter. The customers were also requested to complete and return the enclosed mandatory response form as soon as possible. Any questions were directed to Health O Meter Professional at 800-815-6615 or 708-377-0600.

Device

Health o Meter Professional
  • Modelo / Serial
    Model 498KL, UPC Code - 892076002718, Serial numbers 4980000001 through 4980002909
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) including the countries of Canada, New Zealand, Israel and Lebanon.
  • Descripción del producto
    Health o Meter Professional Remote Display Digital Physician Scale, Model 498KL; digital patient weighing scale; Pelstar LLC, 11800 South Austin Avenue, Unit B, Alsip, IL 60803, U.S.A., Made n China; Model 498KL || Model 498KL scale with remote display head uses sophisticated microprocessor technology. Each instrument is designed to provide accurate, reliable and repeatable weight measurements and features that make the weighing process simple, fast and convenient. The scale is set up to determine the weight of a stationary patient. The weight can be displayed in pounds or kilograms. The unit can be operated by an AC adaptor (optional) or by 6-AA cell batteries (included).
  • Manufacturer
    Pelstar, Llc

Manufacturer

Pelstar, Llc
  • Dirección del fabricante
    Pelstar, Llc, 11800 S Austin Ave, Unit B, Alsip IL 60803-3559
  • Empresa matriz del fabricante (2017)
    Pelstar Llc
  • Source
    USFDA